Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of the proposed study is to investigate the use of resting-state Electroencephalogram (EEG)-Based Brain Entropy (EBDBE) and auditory brainstem responses (ABR) as an objective measure of tinnitus improvement following the use of a bimodal stimulation device in individuals with tinnitus after six weeks of bi-modal stimulation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• 18 years and over at time of consent

• Ability to read and understand English

• Willing and able to provide and understand informed consent

• Willing to commit to the full duration of the investigation

• Subjective tinnitus

• Tinnitus duration of greater than or equal to 3 months and less than or equal to 20 years at time of consent (only for participants in treatment group)

• Baseline THI score from 40 to 76 (only for participants in treatment group)

• Hearing loss condition - can hear the acoustic stimulation of the Lenire device (only for participants in treatment group)

• 18 years and over at time of consent

• Ability to read and understand English

• Willing and able to provide and understand informed consent

• Willing to commit to the full duration of the investigation

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Yezihalem Mesfin
mesri001@umn.edu
763-742-6236
Time Frame
Start Date: 2025-10-03
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 24
Treatments
Experimental: Treatment Group
Use Lenire device for 1 hour daily
No_intervention: Control Group
Participants in the control group will not receive the stimulation device and will not undergo any stimulation during the study.
Related Therapeutic Areas
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov

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